Actively Recruiting
Proton Therapy for Esophageal Cancer
Led by Loma Linda University · Updated on 2025-06-04
38
Participants Needed
1
Research Sites
1014 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this phase II study is to investigate the feasibility, toxicity and efficacy of a regimen incorporating a proven systemic regimen, carboplatin /paclitaxel, with conformal proton modality, followed by definitive surgery. In most combined-modality trials to date, chemotherapy regimens have included cisplatin, usually in conjunction with 5-fluorouracil. In designing the regimen, the investigators attempt to improve on the standard cisplatin/5-fluorouracil regimen in several ways. First, full-dose paclitaxel is added to the regimen. This agent has activity against advanced esophageal cancer and is also a potent radiosensitizer. Second, the substitution of carboplatin for cisplatin has resulted in reduced toxicity of various combination regimens similar to that used by CROSS trial and allows for easier administration in the outpatient setting.4 Third, for localized esophageal cancer, dose distribution patterns achievable with proton beam could potentially offer important clinical advantages relative to those achievable with x-rays (photons).19 Based on this, the investigators believe that this study should be conducted with the radiation modality that offers the best dosimetry achievable at our institution.
CONDITIONS
Official Title
Proton Therapy for Esophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed primary squamous cell or adenocarcinoma of the esophagus involving the mid, distal, or esophagogastric junction, with possible stomach involvement up to 5 cm
- Endoscopy with biopsy confirming diagnosis
- Stage T1N1-2, T2-3N0-2 according to AJCC 7th edition staging
- Recent history and physical exam with weight documentation within 30 days
- Chest, abdominal, and pelvic contrast CT within 56 days
- Whole body PET/CT within 56 days
- Endoscopic ultrasound performed
- Regional adenopathy allowed including para-esophageal, gastric, gastrohepatic, and celiac nodes; celiac adenopathy must be ≤ 2 cm
- Bronchoscopy required for tumors at or above the carina to exclude fistula
- Pulmonary function tests including spirometry and DLCO within 60 days
- Serum creatinine ≤ 2 times upper limit normal within 4 weeks
- Laboratory tests (Na, K, BUN, Glucose, CBC/differential) within 4 weeks with adequate bone marrow function (ANC ≥ 1,500 cells/mm3, platelets ≥ 100,000 cells/mm3, hemoglobin ≥ 8.0 g/dl)
- Adequate liver function (total bilirubin ≤ 1.5 times upper limit, AST ≤ 3 times upper limit) within 4 weeks
- Age 18 years or older
- Zubrod performance status 0-2 within 4 weeks
- Surgical consultation confirming ability to undergo curative surgery after proton chemotherapy
- Negative serum pregnancy test within 14 days for women of childbearing potential
- Adequate contraception use by women of childbearing potential and male participants during study
- Signed informed consent specific to this study
You will not qualify if you...
- Cervical esophageal carcinoma
- T1N0 or T4 stage disease
- Prior radiation therapy for esophageal cancer or prior chest radiotherapy
- Prior chemotherapy for esophageal cancer
- Evidence of tracheoesophageal fistula or invasion into trachea or major bronchi
- Prior invasive malignancy within 2 years except non-melanomatous skin cancer or certain in situ carcinomas
- Prior radiotherapy causing overlapping radiation fields
- Medical contraindications to esophagectomy
- Prior allergic reaction to paclitaxel or carboplatin
- Severe, active co-morbid conditions impacting survival
- Pregnancy, nursing, or unwillingness/inability to use acceptable contraception if sexually active
AI-Screening
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Trial Site Locations
Total: 1 location
1
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Actively Recruiting
Research Team
P
Proton Referral Office First call: Referral Office intake personnel
CONTACT
G
Gary Yang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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